CAT RX Indigo System Mechanical Thrombectomy
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Indigo System
®
Mechanical Thrombectomy
CAT RX
As part of the Indigo Aspiration System, the Indigo CAT RX
Aspiration Catheters and Indigo Separator™ 4 are indicated
for the removal of fresh, soft emboli and thrombi from
vessels in the coronary and peripheral vasculature.
Penumbra ENGINE™
CAT RX
DATA PRESENTED AT ACC 2019
GET THE CLOT OUT FAST
a
“Initial Experience with a Mechanical Aspiration Catheter for Thrombus Removal
Study
During Percutaneous Intervention: A Multicenter Retrospective Case Series”
Key Results
Median
Advanced Trackability Post-CAT RX aspiration Incidence
Seven Material Transitions TIMI 3 flow time with of stroke
CAT RX
With fresh, soft Of patients with an
Design
thrombi in the RCA, occlusion of TIMI 0
Enhanced Deliverability LAD, or Circumflex flow pre-procedure
Proximal Laser Cut Hypotube
Conclusion
Results are encouraging and can be
used to plan future prospective trials.
Maximized Clot Removal
Mathews SJ, Brown C, Kolski B, et al. Initial experience with a mechanical aspiration catheter for thrombus removal during percutaneous intervention: a multicenter retrospective case series.
Large Lumen | 6 F Guide Compatibility Poster presented at: American College of Cardiology’s 68th Annual Scientific Session; March 16-18, 2019; New Orleans, LA.
Rapid Exchange
0.014" Guidewire
Compatibility Removal of Thrombus from Right Coronary Artery
Mechanical Power Aspiration One Touch for
Maximum Aspiration
Easy Setup PRE POST CAT RX 15 seca FINAL
with Penumbra ENGINEb -29 inHg b Hands-Free
Continuous
Dr. Suhail Dohad, Cedars-Sinai Medical Center, CA
Aspiration
30
Removal of Thrombus from Left Anterior Descending Artery
Penumbra ENGINE stays at full
25
vacuum for duration of procedure
Vacuum (-inHg)
20
Live Feedback
During Procedure
15
10
5 Vacuum Drop-off Penumbra ENGINE
PRE POST CAT RX 32 seca FINAL
with Syringe Syringe
60 Dr. Jay Mathews, Manatee Memorial Hospital, FL
Time (sec)
Physician-Controlled Flow Switch
a. Time represents duration of angiogram. Duration of angiogram provided by consenting physician.
b. Tests performed and data on file at Penumbra, Inc. Bench test results may not be indicative of clinical performance. Images used with permission. Consent on file at Penumbra, Inc. Individual results may vary depending on a variety of patient-specific attributes.
Removal of Thrombus from Right Coronary Artery Removal of Thrombus from LIMA Graft
PRE POST CAT RX FINAL
PRE POST PTCA & MANUAL ASPIRATION POST CAT RX & FINAL
Dr. Nainesh Patel, Lehigh Valley Health Network, PA Dr. Larry Diaz, Metro Health-University of Michigan Health, MI
Removal of Thrombus from Left Anterior Descending Artery Removal of Thrombus from Circumflex Artery
Radiopaque Radiopaque
Marker Band Marker Band
PRE INTRA POST CAT RX FINAL PRE INTRA 20 seca POST CAT RX FINAL
Dr. Branavan Umakanthan, Nevada Heart and Vascular Center, NV Dr. Brian Kolski, St. Joseph Hospital, CA
Here’s what physicians are saying about CAT RX:
Jon George Shariq Shamim, MD, FACC
@jcgeorgemd @ShariqShamimMD
To aspirate or not? Still doing it in my acute MI patients with large thrombotic debris. you have to use the device to believe it. You can see thrombus in connection line or
You be the judge. @GPAngioClub @ACVCPhila @penumbrainc canister rest is filled with blood. Really good aspiration when large clot. Cc:
8 July 2019 @bkolskk @AntoniousAttall
18 Aug 2019
Ethan Korngold, MD
@ekgpdx
CatRX via 6F guide. Surprisingly deliverable and the continuous suction is easier to use
Connect with us on Twitter
than manual aspiration devices. I will use if extraordinary thrombus burden. @bkolskk @PenVascular
19 Jun 2019
a. Time represents duration of angiogram. Duration of angiogram provided by consenting physician.
Images used with permission. Consents on file at Penumbra, Inc. Individual results may vary depending on a variety of patient-specific attributes.
Ordering Information
Indigo ® Catheter Kits
Proximal OD Distal OD Compatibility Working Length Wire Platform Compatible
Catalog Number Description (F) (F) (F) (Sheath or Guide) (cm) (in.) Penumbra Devices
Indigo CAT RX +
CATRXKIT – 5.3 6.0 Sheath or Guide 140 .014 Separator™ 4
Large Lumen Aspiration Tubing
Indigo 8 XTORQ Tip +
CAT8XTORQ115KIT 8.0 8.0 8.0 F Sheath 115 .014–.038 Separator 8
Dynamic Aspiration Tubing
Indigo 8 TORQ Tip +
CAT8TORQ85KIT 8.0 8.0 8.0 F Sheath 85 .014–.038 Separator 8
Dynamic Aspiration Tubing
Indigo 8 Straight Tip +
CAT8STR85KIT 8.0 8.0 8.0 F Sheath 85 .014–.038 Separator 8
Dynamic Aspiration Tubing
Indigo 6 +
CAT6KIT 6.0 6.0 6.0 F Sheath 135 .014–.038 Separator 6
Dynamic Aspiration Tubing
Indigo 5 +
CAT5KIT 6.0 5.0 6.0 F Sheath 132 .014–.038 Separator 5
Dynamic Aspiration Tubing
Indigo 3 +
CAT3KIT 4.1 3.4 5.0 F Sheath 150 .014–.025 Separator 3
Dynamic Aspiration Tubing
Indigo D +
CATD 8.0 8.0 8.0 F Sheath 50 .014–.038 Separator D
Large Lumen Aspiration Tubing
Indigo Separators Accessories
Catalog Distal OD Total Length Compatible
Description Catalog Number Description Compatible Penumbra Devices
Number (in.) (cm) Penumbra Devices
SEPC4 Separator 4 .035 200 CAT RX PMXENGN Penumbra ENGINE™ Penumbra ENGINE Canister
SEP8 Separator 8 .072 150 CAT8 IAPS3 Penumbra ENGINE Canister Penumbra ENGINE
SEP6 Separator 6 .055 175 CAT6
assessment of the cause using fluoroscopy. If the cause thrombosis, dissection, or perforation; intimal disruption;
SEP5 Separator 5 .045 175 CAT5 cannot be determined, withdraw the device or system as a myocardial infarction; emergent surgery; fibrillation; hypoten-
unit. Unrestrained torquing or forced insertion of the catheter sion; respiratory failure; peripheral thromboembolic events.
SEP3 Separator 3 .028 190 CAT3 or SEPARATOR against resistance may result in damage to
the device or vessel. PENUMBRA ENGINE – Indication For Use
SEPD Separator D .072 90 CATD • Do not use the INDIGO Aspiration System with a pump other The PENUMBRA ENGINE is indicated as a vacuum source
than the Penumbra Aspiration Pump. for Penumbra Aspiration Systems.
Precautions Contraindications
INDIGO Aspiration Catheters and SEPARATORS – • The INDIGO SEPARATOR is not intended for use as a guidewire. • The safety and effectiveness of this device for use There are no contraindications.
Indication For Use If repositioning of the INDIGO Aspiration Catheter is necessary in the treatment of ST-Elevation Myocardial Infarction Warnings/Precautions
As part of the INDIGO Aspiration System, the INDIGO during the revascularization procedure, such repositioning (STEMI) has not been established. Complications from • The canister is intended for single use only. Do not reuse. Re-
Aspiration Catheters and SEPARATORS are indicated for the should be performed over an appropriate guidewire using the use of this device in this manner could lead to use may result in canister cracking or vacuum filter blockag-
removal of fresh, soft emboli and thrombi from vessels of the standard microcatheter and guidewire techniques. death, permanent impairment, and/or the need for es, which may result in the inability to aspirate.
peripheral arterial and venous systems. • Do not use automated high-pressure contrast injection equip- emergency medical intervention. • Do not block bottom air vents. Unit may overheat and shut
INDIGO Aspiration Tubing – Indication For Use ment with the INDIGO Aspiration Catheter because it may • The device is intended for single use only. Do not resterilize off or fail to restart if run for extended periods of time without
As part of the INDIGO Aspiration System, the INDIGO Sterile damage the device. or reuse. Resterilization and/or reuse may result in ineffective airflow.
catheter coating lubrication, which may result in high friction • To avoid the risk of electrical shock, this equipment must only
Aspiration Tubing is indicated to connect the INDIGO Aspira- Potential Adverse Events
tion Catheters to the Penumbra Aspiration Pump. Possible complications include, but are not limited to, the fol- and the inability to access the target vasculature location. be connected to a supply mains with protective earth.
• Do not use kinked or damaged devices. Do not use open • Do not position the PENUMBRA ENGINE so that it is difficult
Penumbra Aspiration Pump – Indication For Use lowing: allergic reaction and anaphylaxis from contrast me-
dia; acute occlusion; air embolism; arteriovenous fistula; or damaged packages. Return all damaged devices and to remove the power cord. The means of mains disconnect is
The Penumbra Aspiration Pump is indicated as a vacuum to remove the power cord.
source for Penumbra Aspiration Systems. death; device malfunction; distal embolization; emboli; false packaging to the manufacturer/distributor.
• Use prior to the “Use By” date. • Only use replacement fuse with correct rating (see Table 1 for
Contraindications aneurysm formation; hematoma or hemorrhage at access
site; inability to completely remove thrombus; infection; • Use the INDIGO Aspiration System in conjunction with fuse rating).
Not for use in the coronaries or the neurovasculature. fluoroscopic visualization. • Remove and service the PENUMBRA ENGINE if liquids or
hemorrhage; ischemia; kidney damage from contrast
Warnings media; neurological deficits including stroke; vessel spasm, • Maintain a constant infusion of appropriate flush solution. solids have been drawn into the PENUMBRA ENGINE.
• The INDIGO Aspiration System should only be used by physi- • Do not use in the presence of a flammable anesthetic
thrombosis, dissection, or perforation; intimal disruption; • When performing aspiration, ensure that the INDIGO Aspira-
cians who have received appropriate training in interventional tion Tubing valve is open for only the minimum time needed mixture with air or nitrous oxide.
techniques. myocardial infarction; emergent surgery; fibrillation; hypoten-
to remove thrombus. Excessive aspiration or failure to close • Do not use in an oxygen rich environment.
• Do not advance, retract or use any component of the INDIGO
sion; respiratory failure; peripheral thromboembolic events.
the INDIGO Aspiration Tubing valve when aspiration is • To prevent fire or shock hazard, use a replacement power
System against resistance without careful assessment of the INDIGO CAT RX Aspiration Catheters and complete is not recommended. cord of equal rating.
cause using fluoroscopy. If the cause cannot be determined, INDIGO SEPARATOR 4 – Indication For Use • The INDIGO SEPARATOR 4 is not intended for use as a • Do not re-infuse blood or fluid from the canister back into the
withdraw the device or system as a unit. Unrestrained As part of the INDIGO Aspiration System, the INDIGO CAT RX guidewire. patient.
torquing or forced insertion of the catheter or SEPARATOR Aspiration Catheters and INDIGO SEPARATOR 4 are If repositioning of the INDIGO CAT RX Aspiration Catheter is • Do not use petroleum based compounds, acids, caustics,
against resistance may result in damage to the device or indicated for the removal of fresh, soft emboli and thrombi necessary during the revascularization procedure, such re- or chlorinated solvents to clean or lubricate any parts. It
vessel. from vessels in the coronary and peripheral vasculature. positioning should be performed over an appropriate will reduce the service life of the PENUMBRA ENGINE. Use
• Do not use the INDIGO Aspiration System with a pump other only water-based solvents for cleaning.
INDIGO Aspiration Tubing – Indication For Use guidewire using standard guidewire techniques.
than the Penumbra Aspiration Pump. As part of the INDIGO Aspiration System, the INDIGO Sterile • Do not use INDIGO SEPARATOR 4 to macerate or retrieve • Use of this equipment adjacent to or stacked with other
Precautions Aspiration Tubing is indicated to connect the INDIGO CAT RX thrombus distal to the catheter tip. INDIGO SEPARATOR 4 is equipment should be avoided because it could result in
• The device is intended for single use only. Do not resterilize Aspiration Catheters to the Penumbra Aspiration Pump. intended to be used with INDIGO CAT RX Aspiration Catheter improper operation. If such use is necessary, this equipment
or reuse. Resterilization and/or reuse may result in ineffective Penumbra Aspiration Pump – Indication For Use to clear the distal end of the catheter lumen should it be and the other equipment should be observed to verify that
catheter coating lubrication, which may result in high friction The Penumbra Aspiration Pump is indicated as a vacuum blocked with thrombus. they are operating normally.
and the inability to access the target vasculature location. source for Penumbra Aspiration Systems. • Do not use automated high-pressure contrast injection • Portable RF communications equipment (including periph-
• Do not use kinked or damaged devices. Do not use open equipment with the INDIGO CAT RX Aspiration Catheter erals such as antenna cables and external antennas) should
or damaged packages. Return all damaged devices and Contraindications be used no closer than 12 inches (30 cm) to any part of the
The INDIGO Aspiration System is contraindicated in: because it may damage the device.
packaging to the manufacturer/distributor. • The removal of fibrous, adherent or calcified material Potential Adverse Events PENUMBRA ENGINE. Otherwise, this could result in
• Use prior to the “Use By” date. degradation of the performance of this equipment.
(e.g. chronic clot, atherosclerotic plaque) Possible complications include, but are not limited to, the fol-
• Use the INDIGO Aspiration System in conjunction with • Common emitters (such as RFID emitters, security systems,
• The cerebral vasculature lowing: allergic reaction and anaphylaxis from contrast me-
fluoroscopic visualization. dia; acute occlusion; air embolism; arteriovenous fistula; diathermy equipment, and portable transmitters) should not
• Maintain a constant infusion of appropriate flush solution. Warnings be used in close proximity to the PENUMBRA ENGINE as
• The INDIGO Aspiration System should only be used by physi- death; device malfunction; distal embolization; emboli; false
• When performing aspiration, ensure that the INDIGO Aspiration they can interfere with and result in degradation of the perfor-
cians who have received appropriate training in interventional aneurysm formation; hematoma or hemorrhage at access
Tubing valve is open for only the minimum time needed to site; inability to completely remove thrombus; infection; mance of the equipment.
remove thrombus. Excessive aspiration or failure to close the techniques. • Equipment is not safe for MR use.
• Do not advance, retract, or use any component of the hemorrhage; ischemia; kidney damage from contrast
INDIGO Aspiration Tubing valve when aspiration is complete is media; neurological deficits including stroke; vessel spasm, • No modification of this equipment is allowed.
not recommended. INDIGO Aspiration System against resistance without careful
Penumbra, Inc. USA
One Penumbra Place
Alameda, CA 94502
USA
1.888.272.4606
T 1.510.748.3200
F 1.510.748.3232
www.penumbrainc.com order@penumbrainc.com
info@penumbrainc.com
Caution: Federal (USA) law restricts these devices to sale by or on the order of a physician. Prior to use, please refer to the Instructions for Use for complete product indications, contraindications, warnings, precautions, potential
adverse events, and detailed instructions for use. Tests performed and data on file at Penumbra, Inc. Bench test results may not be indicative of clinical performance. Images used with permission. Consents on file at Penumbra, Inc.
Individual results may vary depending on a variety of patient-specific attributes. Please contact your local Penumbra representative for more information.
Copyright ©2019 Penumbra, Inc. All rights reserved. The Penumbra P logos, Indigo, Separator, and Penumbra ENGINE are registered trademarks or trademarks of Penumbra, Inc. in the USA and other countries. All other trademarks are
the property of their respective owners. 15996, Rev. A 08/19 USA
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